Sensitivity of Multiparametric MRI in Differentiation Between Muscle Invasive and Non-muscle Invasive Urinary Bladder Cancer

NCT ID: NCT05324033

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-04-01

Brief Summary

Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans.Therefore, this study will try to evaluate the sensitivity and reliability of mpMRI in accurate diagnosis of cancer bladder.

Primary objective: to detect the sensitivity of multiparametric MRI in differentiation between muscle Invasive and non-muscle invasive Urinary Bladder Cancer in relation to the conventional cystoscopy and histopathological examination of the biopsy.

Conditions

Cancer, Bladder

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

muscle invasive cancer bladder

multiparametric MRI on the bladder

Intervention Type: RADIATION

comparison between mpMRI and histopathology

diagnostic cystoscopy +/- TURBT

Intervention Type: PROCEDURE

conventional way of diagnosis

non-muscle invasive cancer bladder

multiparametric MRI on the bladder

Intervention Type: RADIATION

comparison between mpMRI and histopathology

diagnostic cystoscopy +/- TURBT

Intervention Type: PROCEDURE

conventional way of diagnosis

Interventions

multiparametric MRI on the bladder

comparison between mpMRI and histopathology

Intervention Type: RADIATION

diagnostic cystoscopy +/- TURBT

conventional way of diagnosis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients diagnosed with NMIBC or MIBC during diagnostic cystoscopy or by any radiologic investigation in the Urology department of Helwan university hospitals without being restricted to age or sex.
• All histological types of bladder cancer
• Newly diagnosed, recurrent cases, or even patients undergoing follow-up cystoscopy.

Exclusion Criteria

• Patients with elevated renal function according to their age as this will be a contraindication to DCE MRI.
• Patients with absolute contraindication to MRI (e.g.: metallic prosthesis).
• Patients with contraindication to undergo TURBT (e.g.: unfit for surgery).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mohammad Nagib

Assistant lecturer of urosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Helwan university

Badr, Cairo Governorate, Egypt

Countries

Egypt

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Other Identifiers

REC-FMHU 51/2021

Identifier Type: -

Identifier Source: org_study_id